Insights of biosimilars through SWOT analysis

Figures & data

Figure 1. (A) US FDA-approved products (from 1996 to 2010), (B) Top global biopharmaceutical producers in 2011 (based on revenue), and (C) Global revenue forecast for biosimilars.

Figure 2. (A) Steps involved in the manufacturing process of biosimilars, and (B) Challenges involved in developing biosimilars.

Table 1. Differences between small-molecule drugs/generics and biologics/biosimilars [9].

	Small molecule drugs/Generics	Biologics/Biosimilars
Product-related differences	Molecular weight is low	Molecular weight is high
	Good stability	Sensitive to high temperature and shear rate
	Synthesized by chemical process	Host cell lines are used for preparation
	Physiochemical properties are well defined	Physiochemical properties are complex
	Different routes for administration	Parenterally administered
	Single entity, high chemical purity, purity standards well established	Heterogeneous mixture, broad specification which may change during development, difficult to standardize
	Enters systemic circulation rapidly	Large molecule primarily reaches circulation via lymphatic system, subject to proteolysis during interstitial and lymphatic transit
	Toxicity is specific	Toxicity is receptor mediated
	Non-antigenic in nature	Usually antigenic in nature
Manufacturing differences	Easy reproducibility	Reproducibility is difficult
	Analytical methods can characterize them completely	Difficult to characterize
	Purification is easy	Purification process is complex
	Less chances of contamination	Higher chances of contamination, difficult to detect and removal is even more difficult
	Not much affected by process variations and environment	Highly affected by process variations and environment
Clinical development	Requires only Phase I studies	Requires Phase I and III studies
	Approval procedures are fast	Approval procedures are lengthy and time consuming
	Pharmacovigilance studies are not required	Requires pharmacovigilance and periodic safety update reports
Regulation	Can be substituted automatically	Cannot be substituted automatically
	Bioequivalence needs to be proved	Comparability/similarity needs to be proved
	Registration procedures are established in all regulatory agencies	Registration pathways established in Europe only

Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars 2011;2011:1-11

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